Associates of Otolaryngology, Denver, Colorado, USA.
Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
A prospective randomized controlled study was conducted on patients with chronic rhinosinusitis (CRS) to test the hypotheses that symptom improvement after balloon dilation was noninferior to functional endoscopic sinus surgery (FESS) and balloon dilation was superior to FESS for postoperative debridements.
Adults with uncomplicated CRS of the maxillary sinuses with or without anterior ethmoid disease who met criteria for medically necessary FESS were randomized 1:1 to office balloon dilation or FESS and followed for 6 months. A minimum of 36 patients per arm were required to test the hypotheses with 90% power. Symptom improvement using the validated 20-item Sino-Nasal Outcome Test (SNOT-20) survey, debridements, recovery outcomes, complications, and revision surgeries were compared between groups.
Ninety-two patients (50 balloon dilation; 42 FESS) were treated. Mean SNOT-20 improvement was 1.67 ± 1.10 and 1.60 ± 0.96 in the balloon and FESS arms, respectively. Both groups showed clinically meaningful and statistically significant (p < 0.0001) improvement and the balloon arm was noninferior (p < 0.001) to FESS. The mean number of postprocedure debridements per patient was 0.1 ± 0.6 in the balloon arm versus 1.2 ± 1.0 in the FESS arm, with the balloon group showing superiority (p < 0.0001). Occurrence of postoperative nasal bleeding (p = 0.011), duration of prescription pain medication use (p < 0.001), recovery time (p = 0.002), and short-term symptom improvement (p = 0.014) were all significantly better for balloon dilation versus FESS. No complications occurred in either group and one revision surgery was reported in each arm.
Balloon dilation is noninferior to FESS for symptom improvement and superior to FESS for postoperative debridements in patients with maxillary and anterior ethmoid disease. Balloon dilation is an effective treatment in patients with uncomplicated CRS who meet the criteria for medically necessary FESS.
对慢性鼻-鼻窦炎（CRS）患者进行了一项前瞻性随机对照研究，以检验以下假设：球囊扩张后的症状改善不劣于功能性内镜鼻窦手术（FESS），且球囊扩张后的术后清创术优于 FESS。
患有上颌窦单纯性 CRS 或合并额窦疾病且符合 FESS 医学必要性标准的成年人，按 1:1 随机分为门诊球囊扩张组或 FESS 组，并随访 6 个月。每组至少需要 36 例患者，以 90%的功效检验假设。使用经过验证的 20 项鼻-鼻窦结局测试（SNOT-20）量表比较两组间的症状改善、清创术、恢复结果、并发症和修正手术。
92 例患者（球囊扩张组 50 例，FESS 组 42 例）接受了治疗。球囊扩张组和 FESS 组的 SNOT-20 平均改善分别为 1.67 ± 1.10 和 1.60 ± 0.96。两组均表现出有临床意义和统计学意义的（p < 0.0001）改善，且球囊扩张组不劣于（p < 0.001）FESS 组。球囊扩张组每位患者的平均术后清创术次数为 0.1 ± 0.6 次，FESS 组为 1.2 ± 1.0 次，球囊扩张组表现出优越性（p < 0.0001）。术后鼻出血的发生（p = 0.011）、处方止痛药使用时间（p < 0.001）、恢复时间（p = 0.002）和短期症状改善（p = 0.014）在球囊扩张组均显著优于 FESS 组。两组均未发生并发症，每组各有 1 例报告修正手术。
在患有上颌窦和额窦疾病的患者中，球囊扩张在症状改善方面不劣于 FESS，且在术后清创术方面优于 FESS。在符合 FESS 医学必要性标准的单纯性 CRS 患者中，球囊扩张是一种有效的治疗方法。
